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Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154462
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Melissa Garrido, VA Boston Healthcare System

Brief Summary:

Background and study aims: Medical scribes are trained paraprofessionals that assist providers with documenting patient encounters. Prior evidence suggests that scribes may be effective in increasing provider productivity and satisfaction, and decreasing provider time spent on documentation without negatively affecting patient satisfaction. Section 507 of the MISSION Act of 2018 mandated a two-year pilot of medical scribes, which will begin in March 2020 in specialty clinics and emergency departments (EDs) of twelve VA Medical Centers (VAMCs) across the country. The aims of this study are to understand how the introduction of scribes and scribe training affect provider efficiency, patient and provider satisfaction, wait times, and daily patient volume in the VA context.

Who can participate? Urban and rural VAMCs willing to be assigned medical scribes for use in EDs or selected high wait time specialty clinics (cardiology, orthopedics).

What does the study involve? Four medical scribes will be assigned to each of the 12 VAMC sites randomized into treatment with the VA hiring half as new employees and contracting out for the remaining half. 30% of the scribes will be assigned to emergency departments and the other 70% will be assigned to specialty care. Remaining sites that expressed interest in the pilot but were not randomized treatment will be used as comparators. Provider productivity, patient volume, wait times, and patient satisfaction from the treated sites will be compared to baseline (pre-scribe) data as well as data from comparison sites.

What are the possible benefits and risks of participating? VAMCs where medical scribes are introduced may see gains in provider efficiency, reduced wait times, and increased patient satisfaction due to the shifting of administrative burdens associated with documenting patient encounters in electronic health records from providers to these trained professionals. The introduction of medical scribes could complicate patient encounters by making some patients and/or providers uncomfortable.

Where is the study run from? This study is being coordinated by the Partnered Evidence-based Policy Resource Center (PEPReC) at the VA Boston Healthcare System in collaboration with the VA Office of Veterans Access to Care (OVAC).

When is the study starting and how long is it expected to run for? March 2020 to February 2022

Who is funding the study? U.S. Veterans Health Administration


Condition or disease Intervention/treatment Phase
Medical Scribes Other: Scribes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A two-arm randomized field experiment is being used to assess the effect of medical scribes on productivity, wait times, and patient satisfaction. OVAC will work with participating VAMCs to identify providers to participate in the pilot. A varied provider pool will limit selection bias but must be balanced with recruitment and retention of providers. The goal is to keep the provider-scribe pairs consistent throughout the pilot.

Each VAMC site randomized to treatment will have two VA employee scribes and two contract scribes. Two medical scribes, ideally one employee and one contract, will be assigned to one physician, with two physicians and/or Licensed Independent Practitioners (LIP) participating at each facility. Scribes will work with others if the provider partner is not available during a scheduled shift. Power analyses have been conducted to determine the minimum effect size for each outcome with 80% power, which will be useful for putting the final results into context.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Use of Medical Scribes on Provider Efficiency, Patient Satisfaction, and Wait Times in VAMC Emergency Departments and Specialty Care Clinics
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
No Intervention: No intervention
The VAMC sites randomized to the comparison arm will not have medical scribes introduced into emergency departments or specialty clinics.
Experimental: Treatment
The VAMC sites randomized to the treatment arm are each expected to have four medical scribes, with two being VA employees and two being contractors, introduced into emergency departments or specialty clinics to assist providers during patient encounters.
Other: Scribes
Section 507 of the MISSION Act of 2018 mandates a two-year pilot of medical scribes in VA specialty clinics and emergency departments. Medical scribes assist health care providers by helping to administratively expedite an episode of care through the recording of patient information and updating patient records. Scribes are trained but non-licensed professionals, often deployed in emergency departments and outpatient clinic settings, that observe and document patient encounters but do not participate in clinical care.




Primary Outcome Measures :
  1. Pay period work relative value-based provider efficiency [ Time Frame: Approximately 42 months ]
    Pay period work relative value-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments

  2. Pay period visit-based provider efficiency [ Time Frame: Approximately 42 months ]
    Pay period visit-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments

  3. Daily visit-based provider efficiency [ Time Frame: Approximately 42 months ]
    Daily visit-based provider efficiency is measured using monthly-based provider efficiency, scaled by full-time-equivalent days; this is based on administrative data collected by the VA Corporate Data Warehouse in pay period increments

  4. Days to completed consult [ Time Frame: Approximately 42 months ]
    Days to completed consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments

  5. Days to scheduled consult [ Time Frame: Approximately 42 months ]
    Days to scheduled consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments

  6. Unique patient volume [ Time Frame: Approximately 42 months ]
    Unique patient volume is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments

  7. Patient satisfaction [ Time Frame: Approximately 42 months ]
    Patient satisfaction is measured using V-Signals survey data collected by the VA Office of Veterans Experience in pay period increments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Expression of interest by VAMC

Exclusion Criteria:

• Lack of appropriate site capabilities

The VA Office of Veterans Access to Care developed a list of 32 interested VAMCs based on email surveying, which were categorized based on location (urban, rural), desired scribe deployment (ED, specialty care), and underserved (based on high new patient specialty care wait times). 12 VAMCs were then randomly selected for the treatment, accounting for the requirements of the law, OVAC preferences, and site capabilities, with the remainder used as comparison sites.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154462


Contacts
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Contact: Steven Pizer, PhD (857) 364-6061 peprec@va.gov

Locations
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United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
United States, Kentucky
Robley Rex VA Medical Center Recruiting
Louisville, Kentucky, United States, 40206
United States, Maine
Togus VA Medical Center Recruiting
Augusta, Maine, United States, 04330
United States, Montana
Fort Harrison VA Medical Center Recruiting
Helena, Montana, United States, 59636
United States, New Hampshire
Manchester VA Medical Center Recruiting
Manchester, New Hampshire, United States, 03104
United States, New Jersey
East Orange VA Medical Center Recruiting
East Orange, New Jersey, United States, 07018
United States, North Dakota
Fargo VA Medical Center Recruiting
Fargo, North Dakota, United States, 58102
United States, Oklahoma
Oklahoma City VA Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Audie L. Murphy VA Hospital Recruiting
San Antonio, Texas, United States, 78229
Olin E. Teague Veterans' Medical Center Recruiting
Temple, Texas, United States, 76504
United States, Virginia
Hampton VA Medical Center Recruiting
Hampton, Virginia, United States, 23667
United States, West Virginia
Louis A. Johnson VA Medical Center Recruiting
Clarksburg, West Virginia, United States, 26301
Sponsors and Collaborators
VA Boston Healthcare System
US Department of Veterans Affairs
Investigators
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Principal Investigator: Steven Pizer, PhD Boston VA Healthcare System
Additional Information:
Publications:
Pearson, E., Frakt, A., & Pizer, S. (2018, December). Medical Scribes, Productivity, and Satisfaction. Partnered Evidence-based Policy Resource Center Policy Brief, 3(2).

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Responsible Party: Melissa Garrido, Associate Director, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT04154462    
Other Study ID Numbers: PEPReC Protocol #2019-001
VA QUERI PEC #16-001 ( Other Grant/Funding Number: VA QUERI )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa Garrido, VA Boston Healthcare System:
workforce
medical records
documentation
efficiency
patient satisfaction
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes